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AURIS MEDICAL BEGINS STUDY OF TINNITUS TREATMENT

February 26, 2007

Auris Medical has initiated its first clinical trial with AM-101, its investigational drug for the treatment of inner-ear tinnitus. The primary objective of the double-blind, randomized, placebo-controlled trial with dose escalation is to evaluate the safety of intratympanically delivered AM-101 in patients suffering from tinnitus following acute noise trauma. The secondary objective of the study is a preliminary evaluation of the potential therapeutic benefit of AM-101.

Patients whose tinnitus set in less than three months ago and proved to be refractory to a first-line treatment with glucocorticoids will be enrolled in a maximum of four dose cohorts.

AM-101 is a small molecule that selectively blocks NMDA receptors in the cochlea. NMDA receptors can provoke aberrant activity of the auditory nerve, which is perceived as tinnitus. NMDA receptors do not seem to be involved in fast excitatory neurotransmission, which is essential for hearing, but may be activated due to some excitotoxic incident such as noise trauma or sudden deafness.

It has been shown in preclinical studies that the local administration of AM-101 to animals suffering from tinnitus effectively suppressed the perception of the phantom sound.